Research Scientist - Regulatory Submission / GMP

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

• Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical CMC areas (e.g., registrational CQAs, control strategy, justification of specifications, and comparability studies).
• Act as analytical method Subject Matter Expert (SME).
• Author and/or review technical documents such as method development reports, method validation protocols, bridging, comparability and technical transfer protocols and reports.
• Assist with QMS activities (Change Control, Impact Assessment, Change Action Owner) related to methods, CMC strategy implementation & related activities.
• Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization.  
• Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and ongoing product lifecycle activities.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through commercialization.
• Demonstrated experience in SOP and technical report writing, especially validation and technical transfer, regulatory documents, (e.g. BLA and RoW submission) is highly desired.
• Strong technical writing skills are essential; regulatory writing experience (e.g., eCTD Module 3 sections and/or responding to health authority responses) is highly desirable. 
• Demonstrated experience in developing and designing method transfer and validation studies per ICH and FDA guidelines is highly desired.
• Proficiency in analytical techniques, such as HPLC, CE, iCIEF, LC-MS, Titer, SoloVPE, and impurity methods.
• Prior experience with reference material qualification and inventory management is a plus.
• Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus.
• Familiarity with GMP, GLP and regulatory guidance such as ICH, USP/EP/JP, applicable to analytical methods and commercial-stage CMC. Strong understanding of analytical support for commercial biological products and cGMP manufacturing.
• Proven ability to manage multiple priorities, meet timelines, and maintain flexibility in a fast-paced environment.
• Effective collaboration, communication, prioritization, and multitasking skills.
• Familiarity with commercial program lifecycle, QMS systems, and regulatory submission expectations is preferred 
• Proficiency in statistical analysis tools (e.g., JMP, GraphPad Prism) is desired.

Working Environment:

• Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with
• proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards